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Archive for the ‘Stem Cell Therapy’ Category

Painful Decisions Coming Up at Stem Cell Agency

Sunday, May 20th, 2012


The
Sacramento Bee
today ran a piece by yours truly in its California
Forum
section.

Here
is an excerpt. You can find the entire article here.

"They're
talking about pain at the $3 billion 
California stem
cell agency. And mortality. But not the end of life as you and I know
it.

"They're
talking about the pain that comes from cutting off millions of
dollars for scientists. They're talking about what will happen when
the state stops borrowing money to finance 
stem
cell research
 –
a final-breath moment that arrives in about five years....

"CIRM's
changing priorities create 'stark tension,' said one board
member, Michael Friedman, CEO of the City of Hope in the Los Angeles
area, in January. 'We're going to have to make some really
painful and difficult decisions,' he told directors.

"CIRM's
success – or lack of it – will play a critical role in its future
finances, whether they are based on another bond measure or private
support."

Source:
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Burnham’s Lipton Appeals Rejection of $5 Million Grant Application

Sunday, May 20th, 2012


Sanford-Burnham researcher Stuart
Lipton
is seeking to overturn rejection of his application for a $5
million grant from the California stem cell agency, declaring that
reviewers misinterpreted the proposal and relied partly on
"grantsmanship" instead of science.
Lipton's proposal deals with strokes
and is one of 22 rejected by CIRM's reviewers in a $95 million
round that comes before the agency's directors next Thursday.
Lipton's letter to CIRM yesterday said
some of the reviewers' criticism was "completely unfounded,"
"incorrect" or "in error." The two-page letter
went into specific scientific detail.
In a cover letter to the CIRM board,
CIRM President Alan Trounson said Lipton's appeal was "without
merit." He did not go into details but said CIRM staff is
prepared to discuss it next Thursday.
The scientific score on Lipton's grant
was not disclosed by CIRM, but it appears to be between 62 and 53.
Two grants ranked at 53 were approved by reviewers. Appeals from
rejected scientists are included in the agenda material presented by
the board, but the board does not have to act on them or discuss them.
Researchers can also appear before the board to make a case.
Kristiina Vuori, president of
Sanford-Burnham, is a member of the CIRM board. She will be barred
from taking part in any discussion of Lipton's application or voting
on it.

Source:
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CIRM’s Improving Openness

Sunday, May 20th, 2012


The California stem cell agency this
week once again posted in a timely fashion important information
dealing with matters to be decided next Thursday by directors of the
$3 billion stem cell agency.
The agency's actions are a marked
improvement in openness and transparency compared to the practices
prior to the election last June of J.T. Thomas as chairman of the
CIRM board. Previously, background material on multimillion dollar
matters was not available much of the time until shortly before the directors meeting, making it virtually impossible for interested
parties or the public to comment or attend the sessions. Even CIRM directors would complain from time to time about the laggard performance.
According to the agenda, next week's meeting in San Francisco
will include approval of $95 million in new grants, consideration of
the first-ever performance audit of  which made 27
recommendations for improvement, action on the first-ever CIRM directors' code of conduct along with conflict of interest rules, changes in its loan policy and consideration of the agency's
strategy for the next five years.
In addition to the meeting site in San
Francisco, a public teleconference location will be available at UC
San Francisco
, two in Los Angeles and one in La Jolla. Specific
addresses can be found on the meeting agenda.

Source:
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Scripps CEO Joins Stem Cell Agency Board; Love Leaves

Sunday, May 20th, 2012


Michael Marletta
Scripps Photo

State Treasurer Bill Lockyer has
appointed Michael Marletta, president and CEO of the Scripps Research
Institute
, to the 29-member board of directors of the $3 billion
California stem cell agency.

Marletta fills the seat of Floyd Bloom,
also a Scripps executive, who resigned last year. Scripps has
received $45.3 million in funding from CIRM.
In a letter yesterday to the stem cell
agency, Lockyer said Marletta is a member of the National Academy of
Science, American Academy of Arts and Sciences
and the Institute of
Medicine.
Marletta joined Scripps in 2011 and became president in
January.
Prior to that, he was at the University
of California, Berkeley
, where he once served as chairman of the
department of chemistry, among other roles. An item on the Scripps
web site said Marletta "focused his research on the intersection
of chemistry and biology. He is acknowledged as a pioneer in
discovering the role of nitric oxide, a critical player in
communication between cells."
The CIRM board has another vacancy to
fill. Ted Love resigned last month after serving on the board since
its inception in December 2004. CIRM said Love, executive vice
president of Onyx Pharmaceuticals, resigned for personal reasons.
State Controller John Chiang is considering a number of candidates to
replace him. Love was the only African-American on the board.

Source:
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Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient

Sunday, May 20th, 2012


The California stem cell agency will
not renew a contract with a "special advisor" who has been
nominated to the board of directors of a firm that is sharing in a $14.5 million grant from the agency.
She is Saira Ramasastry, managing
partner of LifeSciences Advisory, LLC, of Emerald Lake Hills, Ca.
Ramasastry has worked for CIRM since May of 2010. Last month, she was
nominated to the board of Sangamo BioSciences, Inc., of Richmond, Ca.
Her responsibilities with CIRM have included "industry analysis
and consultation." Sangamo cited her experience with CIRM in its
press release on her nomination. She was also employed as a
consultant by Sangamo, according to the firm.
Ramasastry's dual roles raise obvious
conflict of interest questions. The case highlights the issues
that can arise between CIRM and the biotech industry as the agency
moves to engage industry more closely. CIRM's response additionally
demonstrates a lack of awareness of the potential for serious
mischief or worse when dealing with consultants.
The California Stem Cell Report asked
CIRM on May 6 for comment on the Sangamo-Ramasastry matter. The
questions included whether Ramasastry disclosed to CIRM her work for
Sangamo and whether CIRM took any action per the agency's conflict of
interest code. CIRM did not respond to the question of whether
Ramasastry ever disclosed her ties to Sangamo, which expects to
receive $5.2 million from the CIRM grant if it runs a full four
years.
Here is the text of CIRM's reply today
from spokesman Kevin McCormack.

"Saira Ramasastry was an
independent contractor. As required by law, we do ask independent
consultants to complete Form 700s(statements of economic interests)
if they participate in an agency decision making role. Her role did
not fall into that category - she was identified as a 'special
advisor' in connection with our external review process - and so she
did not have to fill out a Form 700. Her contract with CIRM comes to
an end at the end of June, and she will not be elected to Sangamo's
board of directors until July. Obviously once she is a member of the
Sangamo board she will not be consulting or advising CIRM because of
our strict conflict of interest rules."

(Editor's note: The board election is
June 21, according to the company, not July.)
Our take: CIRM is heavily dependent on
outside contractors. Expenditures for their services are the second
largest item in CIRM's operational budget, exceeded only by salaries
and benefits of regular employees. The responsibilities of outside
contractors cover a wide range of sensitive tasks including computer
system security, development of software that deals with proprietary
information from grant recipients, analysis of confidential business
operations of grant and loan applicants and much more.
The agency needs to know who their
consultants are working for besides CIRM. Whether they make decisions
for CIRM is beside the point. Gathering information that is not
normally accessible to the public can be extremely valuable to
businesses and their competitors as well as applicants for
CIRM's $3 billion. In Ramasastry's case, she was privy to a great
deal of confidential or economically useful information during her work on CIRM's external
review and likely much more.
The use of California's Form 700 is
hardly adequate to assess conflict of interest issues involving
private consultants. The form was developed in the 1970s to deal with
elected officials primarily and provides only the grossest sort of
look at financial holdings and income.
CIRM's current move to embrace industry
requires more scrutiny of conflicting interests – not less. NextThursday the CIRM board will deal with some of its conflict ofinterest rules. It is fine opportunity to ask for a sharper analysis
of conflict issues and consultants with an eye to strengthening CIRM
regulations and ensuring protection of the agency and its grantees'
work – not to mention the interests of the people of California.

Source:
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$95 Million in California Stem Cell Grants: Preview the Spending

Sunday, May 20th, 2012


For those interested in how the
California stem cell agency is going to spend its next $95 million,
you can check out short digests today of the 19 research grant applications, including reviewer comments, that are virtually certain of receiving the cash. 
The applications came in what CIRM
calls its "early translational III" round, which is
scheduled to be acted on by the CIRM board May 24 in San Francisco.
Digests of reviewer comments are
part of the directors' meeting agenda. They include scientific
scores, a statement from the applicant and a summary of what
reviewers had to say during their closed door sessions. But you won't
find the names of the applicants, their institutions or businesses.
The stem cell agency conceals the names of the winners until after
the board acts. Names of the unlucky ones are not disclosed by CIRM.
The agency says it does not want to embarrass anybody including the
institutions involved.
However, persons familiar with the area
of science involved may well be able to discern at least some of the
names of applicants from the information contained in the summaries.
Scientific scores of the successful
applicants ranged from 88 to 53. Nine grants scored higher than 53
but were rejected by reviewers(the Grants Working Group). The panel
turned down 22 applications overall. The CIRM board has final
authority on applications, but has almost never rejected a positive
decision by reviewers. Sometimes, however, it will overrule a
negative decision.
One successful application that was
scored at 53 involved ALS. The $1.7 million proposal was approved
for "programmatic reasons," according to the summary.
Often, programmatic motions for approval are made by CIRM board
members sitting on the review panel. However, the summary did not
disclose who made the motion or the vote. The summary said,

"The programmatic reasons provided
were that ALS is a devastating disease that is not well-represented
in CIRM's portfolio."

The other successful application that
scored at 53 sought $6.3 million for research involving heart
disease. The summary did not clearly identify the specific reason for
approving the grant on a programmatic motion. But it said,

 "The
GWG (grants working group) ... advised as a condition for funding
that the applicant consult additional vector specialists with
translational and clinical experience to select a more appropriate
vector to move this program towards the clinic." 

Again CIRM withheld the vote on the
motion and the name of the person who made the motion.
Applicants who have been rejected by
reviewers can appeal to the full board. So far no appeals have been
publicly posted by CIRM. The success rate on such appeals is mixed.
The translational round was open to
both academics and businesses, which have received a tiny fraction of
CIRM's $1.3 billion in spending so far. Some businesses have
complained publicly and, as well, to a panel of the Institute of
Medicine
that is evaluating CIRM's performance.
The California Stem Cell Report
yesterday asked CIRM for the number of businesses that applied in the
translational round, including the pre-application process, which is
used to whittle down the total number of applications. The request included total numbers as well. CIRM spokesman
Kevin McCormack declined to produce the figures prior to the CIRM
board meeting, saying they "won't be ready" until after the
session.   

Source:
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IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

Sunday, May 20th, 2012


The $3 billion California stem cell
agency is laboring under a range of problems that include protection of
its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month
study said yesterday.
The performance audit by the Moss Adams accounting
firm of Seattle, Wash., made 27 recommendations for improvements,
including more effort to ease strain connected to the agency's
controversial dual executive arrangement. The study said that the
nearly eight-year-old agency has many "opportunities" to
"enhance performance reporting and decision making, strengthen
effectiveness and efficiency, retain essential human resources and
leverage technology."
In response to the report, the stem
cell agency said, "(M)anagement concurs with the findings and
recommendations....The recommendations are focused and constructive.
CIRM is already implementing many of these recommendations, and we
will be investigating the others in the coming months."
The performance audit is the first ever
made of the California Institute for Regenerative Medicine. The
audit is required by state law and was commissioned by the agency at
a cost of $234,944. For years, the agency for years had resisted calls for a
performance audit until it sought legislative approval in 2010 for
removal of a 50-person cap on its staff. Originally, the performance
audit legislation would have put the study in the hands of the only
state body charged with oversight of the agency and its board. CIRM,
however, was successful in lobbying to have that provision removed.
The 54-page report identified once
again a number of issues that have troubled the stem cell agency for
some years. Moss made 12 top priority recommendations, many of which
dealt with information technology and grants management. Many of the
recommendations focused on providing better and faster information on
performance outcomes, which the audit said has been slow to come and
hard to generate.
The report said,

"Key performance information is
not readily available to CIRM leadership and other stakeholders on an
ongoing basis. CIRM board members and senior management do not
receive regularly updated, enterprise-level performance information.
The ability to evaluate performance against strategic goals is
critical to effective leadership and program monitoring, evaluation,
and reporting."

The audit stated,

"CIRM does not effectively
communicate outcome-based performance internally or externally. As
such, CIRM does not focus on performance metrics as part of its
(staff) meeting process."

The report additionally said,

"CIRM does not have an integrated
financial information system....The use of spreadsheets results in
labor intensive processes to generate reports and respond to
information inquiries, since data must be pulled from multiple
spreadsheets, a process that may be prone to error. ...Spreadsheets
are not linked to each other or a master report. CIRM does not have a
comprehensive list of spreadsheets or instructions for how to
maintain the files or generate reports from them."

Moss Adams said that CIRM needed to do
a better job in "bond forecasting," a reference to the
California state bonds that finance virtually every aspect of the
agency's operations. CIRM directors were caught by surprise a few
years ago when they suddenly learned the agency was up against a
major cash crunch.
Some of the recommendations will
require more work from CIRM grantees and their technology transfer
offices in an effort to track intellectual property and grant outcomes.
The report also recommended a speed-up in CIRM's review of progress
reports from grant recipients, which have been lagging completion by
several months.
The dual executive arrangement, which
was written into law by Prop. 71, has troubled CIRM since nearly day
one. CIRM's own external review panel also identified it as problem
two years ago. The executive structure is virtually impossible to
change because of the political difficulty in making alterations in
the ballot initiative.
Moss-Adams said,

"The working relationship between
the chairman’s office and the president’s office has vastly
improved over the past year, but there are still opportunities for
improvement."

The performance audit recommended,

"Make every effort to manage and
operate as one cohesive organization, while recognizing the varying
roles, responsibilities, and authorities that exist with positions in
both the chairman’s office and president’s office."

One of the top 12 recommendations
involved CIRM's public relations/communications effort. CIRM
Chairman J.T. Thomas told directors last June that the agency was in
a "communications war."
Moss-Adams said,

"CIRM does not have a
communication plan, and there is lack of clarity on how to address
mission-based communication to CIRM’s various target audiences,
especially the general public....The best way to facilitate
results-based communications is to 1) quantify goals and outcomes in
CIRM’s strategic plan and 2) report on achievement of those goals
and outcomes by enhancing CIRM’s annual report with additional
performance-based information."

Another performance assessment of the
stem cell agency is also underway. It is being conducted by the
prestigious Institute of Medicine and is costing CIRM $700,000. That
report is expected this fall.
CIRM's board of directors is scheduled
to consider the Moss Adams report at its meeting May 24.
Our take: While the findings and
recommendations of the performance audit were delicately worded in
many cases, they brought out issues that need to be addressed, many
of which have been around for a great deal of time. At their meeting
next week, CIRM directors should act very directly on the
recommendations. They can do that by requiring a written report each
month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson
on the specific steps that they are taking to implement the
performance audit's recommendations. Otherwise, the inevitable drift
will set in.

Source:
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California Budget Slashing Misses Stem Cell Agency

Sunday, May 20th, 2012


The $3 billion California stem cell
agency dodged the governor's financial knife today.
This morning, Gov. Jerry Brown
announced sweeping cuts throughout California state government as he
attempted to close a new, $15.7 billion deficit. A report in the Los
Angeles Times
 said the governor was "grabbing any spare change available." But this afternoon, in response to a
query, Kevin McCormack, CIRM's spokesman, said,

"The answer is no, we won't be
affected."

The question arose because California's
financial picture is much bleaker than it was just four months ago.
And the stem cell agency's only real source of cash is money borrowed
by the state -- general obligation bonds.
Under Prop. 71, which created the
agency in 2004, the bond funds flow directly to the agency without
intervention by the legislature or the governor. However, Brown has
been chary of additional bond sales since they create an increasing
burden in the form of interest costs. Those costs must be financed
out of money that otherwise might go to the University of
California
, K-12 schools and medical help for the poor.
Under an agreement arrived at last year, CIRM has what amounts to a $225 million line of credit with the
state, which should take care of its needs until January. The cash is
coming from short-term borrowing by the state instead of bonds.

The Brown Administration has cut back
on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing
has declined $173 million this fiscal year, down to $5.2 billion.
CIRM's share of the debt service is more than $200,000 a day.  

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Prochymal approval makes Canada first country to OK stem cell therapy

Sunday, May 20th, 2012

Toni Clarke BOSTON Globe and Mail Update Published Friday, May. 18, 2012 12:38PM EDT Last updated Friday, May. 18, 2012 12:56PM EDT

Osiris Therapeutics Inc. OSIR-Q said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 per cent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 per cent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal's future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD those who have more or less failed all other therapies Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 per cent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

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Family hangs hope for boy on unproven therapy in India

Sunday, May 20th, 2012

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

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Medical success or boondoggle?

Sunday, May 20th, 2012

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

More:
Medical success or boondoggle?

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Stem cell banking firms to deploy marketing initiatives to boost sales

Thursday, May 17th, 2012

Kolkata, May 15:

Stem cell banking companies are looking at aggressive marketing initiatives to move into the mass market segment. Direct marketing to customers and reduction in price tag for storing umbilical cord blood are on the cards.

The umbilical cord blood and cord tissue are one of the richest sources of stem cells and have potential to treat over 75 serious ailments.

The average cost for storing these for a period of 21 years ranges between Rs 75,000 and Rs 90,000 in India.

According to Chennai-based Life Cell, high price points and lack of proper marketing have limited the penetration of cord blood banking in India. Affordability is the key factor in India.

Only when the prices come down will we see more customers opting for the service. We are working on it (bringing down prices), Mr Mayur Abhaya Srisrimal, Executive Director Life Cell, told Business Line.

Stem cell bankers have already rolled out easy finance options such as EMIs to make the services attractive. CordLife, for instance, offers EMI facility for 12-24 months.

This has helped boost our sales. We have been acquiring 350-400 clients each month, said Managing Director, Mr Meghnath Roy Chowdhury.

Finance, however, is not the only stumbling block. Cord blood bankers have, so far, been depending largely on hospital network for signing up clients. Bangalore-based Ms Deepa Shankar, who is expecting and is due for delivery in June, recently opted for Life Cell services through the hospital.

It's not a sustainable approach. We need to get into direct marketing for pushing up volumes growth, Mr Srisrimal points out. To strike a cord with the would-be mothers, the company has roped in Lisa Ray as brand ambassador. Ms Ray was cured of multiple myeloma courtesy stem cell therapy.

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Thursday, May 17th, 2012

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the "Save the Chimps" in Florida.

The procedure involves injecting the chimp with her own stem cells.

"With chimps we don't want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing," said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

"We're not using embryonic stem cells, we're not taking embryos and taking their stem cells from there. We're just using the patient's own tissue," said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie's knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

Monday, May 14th, 2012

By Cathy C. Yamsuan Philippine Daily Inquirer

Former President Joseph Erap Estrada had always maintained that giving generously to friends and forgiving opponents are the secrets to staying young.

But time has a way of catching up with even the most formidable leading men.

Since he entered national politics 25 years ago, Estrada has struggled with the attributes of old ageweight gain, a painful knee here, a cataract there.

He needed some kind of elixir of youth to put to right what nature has put asunder. And to get back on his feet in time to serve the people, he said which has no age limit.

So he did it, and is very open about it. What is it?

At the prodding of friends, the 75-year-old Estrada flew to Frankfurt, Germany, last month to undergo fresh cell therapy (also known as stem cell treatment), an innovative albeit controversial procedure where fresh cells from donor animals are injected into the human body to treat diseases or reverse the aging process.

Fresh cell therapy operates under the principle of like heals like.

The fresh cells from a donor animals organ are infused into the human counterpart.

Substances in the donors blood are supposed to reactivate the human bodys immune system and defense mechanism, a reaction that would eventually rebuild and revitalize aging tissues.

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In The Know: Stem cell therapy

Monday, May 14th, 2012

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

Follow this link:
In The Know: Stem cell therapy

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StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

Sunday, May 13th, 2012


StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.
The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.
StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM)
for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California
.
During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.
Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.
StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM. 
StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.
Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

Sunday, May 13th, 2012


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

Sunday, May 13th, 2012


A "special
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
Ramasastry's
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of
directors, said,

 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is
scheduled to vote on Ramasastry's nomination on June 21. 
The California
Stem Cell Report
has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Our take?
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

Sunday, May 13th, 2012


StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.
The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.
StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM)
for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California
.
During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.
Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.
StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM. 
StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.
Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

Sunday, May 13th, 2012


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

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